Investigating SHR-1819 for treating atopic dermatitis in children and adolescents
A Phase Ib/II Study to Investigate the Safety、PK and PD of SHR-1819 in Children and Adolescents With Moderate-to-severe Atopic Dermatitis
PHASE1; PHASE2 · Guangdong Hengrui Pharmaceutical Co., Ltd · NCT06713499
This study is testing a new injection treatment called SHR-1819 to see if it can safely help children and teenagers aged 6 to 17 with moderate-to-severe atopic dermatitis.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Guangdong Hengrui Pharmaceutical Co., Ltd (industry) |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06713499 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety of SHR-1819, an injection treatment, in children and adolescents aged 6 to 17 with moderate-to-severe atopic dermatitis. Participants will be monitored for safety and tolerability throughout the study. The trial aims to gather data that could support further development of this treatment for young patients suffering from this chronic skin condition.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 6 to 17 who have been diagnosed with moderate-to-severe atopic dermatitis.
Not a fit: Patients with other active skin diseases or serious concomitant conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for children and adolescents suffering from moderate-to-severe atopic dermatitis.
How similar studies have performed: While this specific approach is novel, similar studies targeting atopic dermatitis have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects and their parents or legal guardians have voluntarily signed the informed consent form prior to the start of any procedures related to the study, are able to communicate smoothly with the investigator, understand and are willing to strictly comply with the requirements of this clinical study protocol to complete the study; 2. At the time of signing the informed consent, the subjects were ≥ 6 years old and \< 18 years old, male or female; 3. Have atopic dermatitis at screening. Exclusion Criteria: 1. Before enrollment, the subjects weighed \< 15kg; 2. Females who are pregnant or lactating and have a positive pregnancy test result; 3. Have other active skin disease or skin complications due to other conditions that may affect the evaluation of AD; 4. Have serious concomitant diseases and other conditions that the investigator considers inappropriate to participate in this trial; 5. Treated with biologics targeting IL-4Rα , or participated in previous clinical studies of biologics targeting IL-4Rα, including SHR-1819 injection; 6. Has malignancy or has a history of malignancy; 7. Hypersensitivity to the study drug or any ingredient in the study drug.
Where this trial is running
Shenyang, Liaoning
- The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (RECRUITING)
Study contacts
- Study coordinator: Xiaoyan Bai
- Email: xiaoyan.bai.xb1@hengrui.com
- Phone: 0518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Children and Adolescents With Moderate-to-severe Atopic Dermatitis